Evidence map›Paper›PMID 32333154›Full record

Trial reportAnnals of hematology2020

A phase II study of ibrutinib in combination with rituximab-cyclophosphamide-doxorubicin hydrochloride-vincristine sulfate-prednisone therapy in Epstein-Barr virus-positive, diffuse large B cell lymphoma (54179060LYM2003: IVORY study): results of the final analysis.

Sang Eun Yoon, Seok Jin Kim, Dok Hyun Yoon, Youngil Koh, Yeung-Chul Mun, Young Rok Do, Yoon Seok Choi, Deok Hwan Yang, Min Kyoung Kim, Gyeong-Won Lee and 3 more

Open access · hybridAbstract readClinical Trial, Phase IIMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Annals of hematology, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed
1.0field-weighted citation impact, top 24% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

8 citing papers in PubMed, 14 citations in OpenAlex.

  1. Trial
  2. Review
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  8. InactivatingEJHaem · 2022
    Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

13 authors at 9 institutions in 1 country.

Sang Eun YoonDivision of Hematology and Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, 81, Irwon-ro, Gangnam-gu, Seoul, 06351, South Korea.
Seok Jin KimDivision of Hematology and Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, 81, Irwon-ro, Gangnam-gu, Seoul, 06351, South Korea.
Dok Hyun YoonDepartment of Oncology, Asan Medical Center, Ulsan University College of Medicine, Seoul, South Korea.
Youngil KohDepartment of Internal Medicine, Seoul National University Hospital, Seoul, South Korea.
Yeung-Chul MunDepartment of Hematology-Oncology, Ewha Womans University Mokdong Hospital, Seoul, South Korea.
Young Rok DoDepartment of Hematology-Oncology, Keimyung University School of Medicine, Daegu, South Korea.
Yoon Seok ChoiDepartment of Internal Medicine, Chungnam National University College of Medicine, Daejeon, South Korea.
Deok Hwan YangDivision of Hematology-Oncology, Chonnam National University Hwasun Hospital, Hwasun, South Korea.
Min Kyoung KimDepartment of Internal Medicine, Yeungnam University College of medicine, Daegu, South Korea.
Gyeong-Won LeeDivision of Hematology-Oncology, Department of Internal Medicine, Gyeongsang National University College of Medicine, Gyeongsang National University Hospital, Jinju, South Korea.
Cheolwon SuhDepartment of Oncology, Asan Medical Center, Ulsan University College of Medicine, Seoul, South Korea.
Young Hyeh KoDepartment of Pathology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea.
Won Seog KimDivision of Hematology and Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, 81, Irwon-ro, Gangnam-gu, Seoul, 06351, South Korea. wskimsmc@skku.edu.
Samsung Medical Center · KRAsan Medical Center · KRChonnam National University Hwasun Hospital · KRChungnam National University · KREwha Womans University · KRGyeongsang National University Hospital · KRKeimyung University · KRSeoul National University Hospital · KRYeungnam University College

Funding

Foundation of Shanxi Province Key Laboratory of Functional Nanocomposites NFCM201605Natural Science Foundation of Shanxi Province 201801D121069
6 · The paper itself

Abstract

Epstein-Barr virus (EBV) positivity in diffuse large B cell lymphoma (DLBCL) provokes a critical oncogenic mechanism to activate intracellular signaling by LMP1. LMP1 specifically mimics the role of BTK-dependent B cell receptor. Therefore, a trial considering RCHOP therapy along with ibrutinib (I-RCHOP) in combination was conducted among patients with EBV-positive DLBCL. This study was an open-label, single-arm, prospective multicenter phase II clinical trial. Patients received 560 mg of ibrutinib with RCHOP every 3 weeks until 6 cycles were completed or progression or unacceptable toxicity was observed. The primary endpoint was objective response, while secondary endpoints included toxicity, progression-free survival, and overall survival. A matched case-control analysis was completed to compare the efficacy and toxicity of I-RCHOP and RCHOP, respectively, in EBV-positive DLBCL patients. From September 2016 to August 2019, 24 patients proven to have EBV-positive DLBCL in the tissue were enrolled and received I-RCHOP. Their median age was 58 years (range, 28-84 years). The objective overall response was 66.7%, including 16 patients who achieved complete response after 6 cycles. Patients aged younger than 65 years presented a superior OR (87.5%) as compared with those older than 65 years (25.0%; p = 0.01). In a matched case-control study, I-RCHOP therapy provoked a more favorable complete response rate (87.3%) than did RCHOP (68.8%) in those younger than 65 years. Treatment-related mortality was linked most frequently with I-RCHOP therapy (four patients presented with unusual infection without Gr3/4 neutropenia) in the older age group (age ≥ 65 years). In conclusion, in this phase II trial for EBV-positive DLBCL, I-RCHOP was effective but did not show a significant improvement in response and survival in comparison with RCHOP. Also, I-RCHOP promoted serious toxicity and treatment-related death in older patients.

Indexed as

AdenineAdultAgedAged, 80 and overAntineoplastic Combined Chemotherapy ProtocolsCase-Control StudiesCyclophosphamideDoxorubicinEpstein-Barr Virus InfectionsFemaleFollow-Up StudiesHumansLymphoma, Large B-Cell, DiffuseMaleMiddle AgedPiperidinesAdenineCyclophosphamideDoxorubicinibrutinibPiperidinesPrednisonePyrazolesPyrimidinesRituximabVincristineDiffuse large B cell lymphomaEpstein-Barr virus-positiveIbrutinibR-CHOP

Identifiers

PMID32333154
PMCPMC7237534
OpenAlexW3020171238

What OpenQuestion holds

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LicenceCC BY
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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.